ONGLYZA 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Onglyza 2.5mg film-coated tablets

saxagliptin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Onglyza is and what it is used for
2. What you need to know before you take Onglyza
3. How to take Onglyza
4. Possible side effects
5. Storage of Onglyza
6. Contents of the pack and other information

1. What Onglyza is and what it is used for

Onglyza contains the active substance saxagliptin which belongs to a group of medicines called “oral anti-diabetics”. They help to control the level of sugar in your blood.

Onglyza is used to treat adult patients aged 18 years or older with “type 2 diabetes”, if the disease cannot be controlled adequately with a single oral anti-diabetic medicine, diet, and exercise. Onglyza is used alone or in combination with insulin or other anti-diabetic medicines.

It is important that you follow the advice about diet and exercise given by your doctor or healthcare professional.

2. What you need to know before you take Onglyza

Do not take Onglyza

• if you are allergic to saxagliptin or any of the other ingredients of this medicine (listed in section 6).
• if you have had a severe allergic reaction to any other medicine used to control blood sugar levels. See section 4.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Onglyza:

• if you are taking insulin. Onglyza must not be used to replace insulin;
• if you have type 1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar levels, rapid weight loss, nausea, or vomiting). Onglyza must not be used to treat these conditions;
• if you have or have had pancreatic disease;
• if you are taking insulin or an anti-diabetic medicine known as a “sulphonylurea”, your doctor may want to reduce your dose of insulin or sulphonylurea when you take either of them with Onglyza to avoid low blood sugar levels;
• if you have a condition that reduces your immune system, such as an illness like AIDS or medicines you may take after an organ transplant;
• if you have heart failure or other risk factors for developing heart failure such as kidney problems. Your doctor will tell you about the signs and symptoms of heart failure. You should contact your doctor, pharmacist, or nurse immediately if you experience any of these symptoms. The symptoms can include, but are not limited to, increasing shortness of breath, rapid weight increase, and swelling of the feet (oedema).
• if you have reduced kidney function, your doctor will decide if you need a lower dose of Onglyza. If you are on dialysis, then Onglyza is not recommended for you;
• if you have moderate or severe liver problems. If you have severe liver problems, then it is recommended that you do not use Onglyza.

Diabetic skin lesions are a common complication of diabetes. Skin rash has been observed with Onglyza (see section 4) and with certain anti-diabetic medicines in the same class as Onglyza. You are advised to follow the skin and foot care recommendations given by your doctor or healthcare professional. Contact your doctor if you find blisters on your skin, as it may be a sign of a disease called bullous pemphigoid. Your doctor may ask you to stop taking Onglyza.

Children and adolescents

Onglyza is not recommended for children and adolescents under 18 years of age.

Other medicines and Onglyza

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

In particular, you should tell your doctor if you are using medicines that contain any of the following active substances:

• Carbamazepine, phenobarbital, or phenytoin. These may be used to control epilepsy (seizures) or chronic pain.
• Dexamethasone – a steroid medicine. It may be used to treat inflammation in different parts of the body and organs.
• Rifampicin. This is an antibiotic used to treat infections such as tuberculosis.
• Ketoconazole. It may be used to treat fungal infections.
• Diltiazem. This is a medicine used to lower blood pressure.

Pregnancy and breast-feeding

Consult your doctor before taking Onglyza if you are pregnant or planning to become pregnant. You must not use Onglyza if you are pregnant.

Consult your doctor if you want to breast-feed while taking this medicine. It is not known if Onglyza passes into human breast milk. You must not take this medicine if you are breast-feeding or planning to breast-feed.

Driving and using machines

If you feel dizzy while taking Onglyza, do not drive or use tools or machines. Hypoglycaemia can affect your ability to drive or use machines or work with a firm support and there is a risk of hypoglycaemia when taking this medicine in combination with medicines with a known effect of hypoglycaemia, such as insulin or sulphonylureas.

Onglyza contains lactose

The tablets contain lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Onglyza contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How to take Onglyza

Follow exactly the instructions of administration of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 5 mg once a day.

If you have reduced kidney function, your doctor may prescribe a lower dose. This is a 2.5 mg tablet once a day.

Your doctor may prescribe Onglyza alone or in combination with insulin or other anti-diabetic medicines. If so, remember to take these other medicines as directed by your doctor to achieve the best results for your health.

How to take Onglyza

The tablets must not be divided or crushed. Swallow the whole tablet with a little water. You can take the tablet with or without food. The tablet can be taken at any time of the day, however, try to take the tablet at the same time each day. This will help you remember to take it.

If you take more Onglyza than you should

If you take more tablets than you should, consult a doctor immediately.

If you forget to take Onglyza

• If you forget to take a dose of Onglyza, take it as soon as you remember. However, if it is nearly time for your next dose, do not take the missed dose.
• Do not take a double dose to make up for a forgotten dose. Never take two doses on the same day.

If you stop taking Onglyza

Continue to take Onglyza until your doctor tells you to stop. This is to help you keep your blood sugar levels under control.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some symptoms need immediate medical attention:

You should stop taking Onglyza and contact your doctor immediately if you experience the following symptoms of low blood sugar: shaking, sweating, anxiety, blurred vision, tingling of the lips, paleness, mood changes, disorientation, or confusion (hypoglycaemia); very common (may affect more than 1 in 10 patients).

The symptoms of a severe allergic reaction (rare, may affect up to 1 in 1,000 patients) can include:

• Skin rash.
• Red raised patches on the skin (hives).
• Swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.

If you experience any of these symptoms, stop taking Onglyza and contact your doctor or nurse immediately. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.

You should stop taking Onglyza and contact your doctor immediately if you notice any of the following serious side effects:

• Severe and persistent abdominal pain (in the stomach area) that may radiate to the back, as well as nausea and vomiting, which could be a sign of having an inflamed pancreas (pancreatitis).

You should contact your doctor if you experience the following side effect:

• Severe joint pain.

Some patients have experienced the following side effects while taking Onglyza and metformin:

• Common (may affect up to 1 in 10 patients): chest or lung infection, urinary tract infection, inflammation of the stomach or intestine, normally caused by an infection (gastroenteritis), infection of the nasal passages with a feeling of pain and pressure behind the cheekbones and eyes (sinusitis), inflammation of the nose or throat (nasopharyngitis) (the signs of this may include a cold or sore throat), headache, muscle pain (myalgia), vomiting, stomach inflammation (gastritis), stomach pain, and indigestion (dyspepsia).

• Uncommon (may affect up to 1 in 100 patients): joint pain (arthralgia) and difficulty having or maintaining an erection (erectile dysfunction).

Some patients have experienced the following side effects while taking Onglyza and a sulphonylurea:

• Very common: low blood sugar levels (hypoglycaemia).
• Common: chest or lung infection, urinary tract infection, inflammation of the stomach or intestine, normally caused by an infection (gastroenteritis), infection of the nasal passages with a feeling of pain and pressure behind the cheekbones and eyes (sinusitis), headache, stomach pain, and vomiting.

• Uncommon: tiredness, abnormal levels of lipids (fatty acids) (dyslipidaemia, hypertriglyceridaemia).

Some patients have experienced the following side effects while taking Onglyza and a thiazolidinedione:

• Common: chest or lung infection, urinary tract infection, inflammation of the stomach or intestine, normally caused by an infection (gastroenteritis), infection of the nasal passages with a feeling of pain and pressure behind the cheekbones and eyes (sinusitis), headache, vomiting, stomach pain, and swelling of the hands, ankles, or feet (peripheral oedema).

Some patients have experienced the following side effects while taking Onglyza and metformin and a sulphonylurea:

• Common: dizziness, tiredness, stomach pain, and flatulence.

Some patients have experienced the following additional side effects while taking Onglyza alone:

• Common: dizziness, diarrhoea, and stomach pain.

Some patients have experienced the following side effects while taking Onglyza alone or in combination:

• Frequency not known (cannot be estimated from the available data): constipation, appearance of blisters on the skin (bullous pemphigoid).

Some patients have experienced a small reduction in the number of a type of white blood cell (lymphocytes) detected by blood analysis while taking Onglyza alone or in combination.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Onglyza

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP/CAD. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Do not use this medicine if the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Onglyza contains

• The active substance is saxagliptin. Each film-coated tablet contains 2.5 mg of saxagliptin (as hydrochloride).

• The other ingredients are:

• Tablet core: lactose monohydrate; microcrystalline cellulose (E460i); sodium croscarmellose (E468); magnesium stearate.
• Coating: polyvinyl alcohol; macrogol 3350; titanium dioxide (E171); talc (E553b), and yellow iron oxide (E172).
• Printing ink: shellac; aluminium lake of carmine indigo (E132).

Appearance and packaging

• The 2.5 mg film-coated tablets are pale yellow to light yellow, biconvex, and round. They are marked “2.5” on one face and “4214” on the other, in blue ink.
• The tablets are packaged in aluminium blisters.
• The 2.5 mg tablets are available in pack sizes of 14, 28, or 98 film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit-dose blisters.

Not all pack sizes may be marketed in your country.

Marketing authorisation holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE‑152 57 Södertälje

Sweden

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

Cheshire

SK10 2NA

United Kingdom

You can get more information about this medicine by contacting the representative of the marketing authorisation holder in your country:

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.